Treatment of Gastroesophageal Reflux Disease in 12-16 Year Old Patients With Rabeprazole

This study has been completed.

Sponsor:

Information provided by:

Eisai Inc.

ClinicalTrials.gov Identifier:

NCT00132496

First received: August 19, 2005

Last updated: November 2, 2009

Last verified: November 2009

History of Changes

Results First Received: August 25, 2009

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Gastroesophageal Reflux Disease
Intervention:	Drug: rabeprazole sodium

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
This study was recruited at 25 centers in the US during the period of 18-Aug-2005 and 1-May-2006.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
There was a screening period of up to 2 days before treatment assignment

Reporting Groups

	Description
Rabeprazole 10 mg	once daily for 8 weeks
Rabeprazole 20 mg	once daily for 8 weeks

Participant Flow: Overall Study

	Rabeprazole 10 mg	Rabeprazole 20 mg
STARTED	54	57
COMPLETED	52	55
NOT COMPLETED	2	2
Withdrawal by Subject	1	2
Physician Decision	1	0

Baseline Characteristics

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Reporting Groups

	Description
Rabeprazole 10 mg	once daily for 8 weeks
Rabeprazole 20 mg	once daily for 8 weeks
Total	Total of all reporting groups

Baseline Measures

	Rabeprazole 10 mg	Rabeprazole 20 mg	Total
Number of Participants [units: participants]	54	57	111
Age [units: years] Mean ± Standard Deviation	14.2 ± 1.3	14.1 ± 1.5	14.2 ± 1.4
Gender [units: participants]
Female	27	26	53
Male	27	31	58
Race/Ethnicity, Customized [units: participants]
Asian	0	0	0
Black or African American	4	1	5
White	47	53	100
Hispanic	1	2	3
Other	2	1	3
Region of Enrollment [units: participants]
United States	54	57	111

Outcome Measures

1. Primary:

Treatment-emergent Adverse Events Experienced by >=5% of Patients in Any Treatment Group [ Time Frame: 8 weeks from randomization and end of treatment ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: No text entered.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact:

Name/Title: Yufang Lu, MD, PhD, Study Director
Organization: Eisai Medical Research Inc.
phone: 201-403-2500

No publications provided

Responsible Party:	Yufang Lu, Study Director, Eisai Medical Research Inc.
ClinicalTrials.gov Identifier:	NCT00132496 History of Changes
Other Study ID Numbers:	E3810-A001-202
Study First Received:	August 19, 2005
Results First Received:	August 25, 2009
Last Updated:	November 2, 2009
Health Authority:	United States: Food and Drug Administration

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